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A Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US
 
Region Sponsors
California - Northern
GlaxoSmithKline
 
Acronym KP IRB No.
1429538
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with HIV Infections.
 
Purpose
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.
 
Detailed Description
Change from Baseline in the acceptability of intervention measure (AIM) questionnaire in staff study subjects based on Likert scale [ Time Frame: Baseline and 4 months ]. The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for AIM in staff study subjects [ Time Frame: Baseline and 12 months ]. The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for AIM in subjects with HIV infection at 4 months [ Time Frame: Baseline and 4 months ]. The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for AIM in subjects with HIV infection [ Time Frame: Baseline and 12 months ]. The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for intervention appropriateness measure (IAM) in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]. The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for IAM in staff study subjects [ Time Frame: Baseline and 12 months ]. The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for IAM in subjects with HIV infection [ Time Frame: Baseline and 12 months ]. The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for IAM in subjects with HIV infection at 4 months [ Time Frame: Baseline and 4 months ]. The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for feasibility of intervention measure (FIM) in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]. The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes. Change from Baseline for FIM in staff study subjects [ Time Frame: Baseline and 12 months ]. The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Be able to understand and comply with protocol requirements, instructions, and restrictions
  • Understand the long-term commitment to the study and be likely to complete the study as planned
  • Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.)
  • All Participants eligible for enrolment in the study must meet all of the following criteria: Aged 18 years or older at the time of signing the informed consent
  • HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA >/=200 c/mL)
  • Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus
  • INI (either the initial or second Combination antiretroviral therapy (cART) regimen)
  • NNRTI (either the initial or second cART regimen)
  • Boosted prediction interval (PI) (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability)
  • Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV
  • Please contact study team for more eligibility criteria.
 
Exclusion Criteria
  • Within 6 months prior to Screening, plasma HIV-1 RNA measurement >/=50 c/mL
  • During the previous 12 months, any confirmed HIV-1 RNA measurement >/=200 c/mL Exclusionary medical conditions
  • Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study
  • Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and Cluster of Differentiation (CD4+) counts
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low
  • Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk
  • The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions
  • Please contact study team for more eligibility criteria.

 
Keywords and/or Specific Medical Conditions
  • Allergy and Immunology
  • Molecular Mechanisms of Pharmacological Action
  • Anti-HIV Agents
  • Nucleic Acid Synthesis Inhibitors
  • Anti-Infective Agents
  • Retroviridae Infections
  • Anti-Retroviral Agents
  • Reverse Transcriptase Inhibitors
  • Antiviral Agents
  • Rilpivirine
  • Enzyme Inhibitors
  • RNA Virus Infections
  • HIV Infections
  • Sexually Transmitted Diseases
  • Immune System Diseases
  • Sexually Transmitted Diseases, Viral
  • Immunologic Deficiency Syndromes
  • Virus Diseases
  • Lentivirus Infections
  • Infectious Diseases
 
KP Clinical Facility
  • Sacramento Medical Center
 
Clinical Area
  • Allergy and Immunology
  • Infectious Diseases


Principal Investigator:
Jason Flamm, MD
Contact Information:
- Susan Campbell
-Susan.Campbell@kp.org
-Sacramento Medical Center


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